A Phase I Single Blind, Randomized, Placebo Controlled, Parallel Group Study to Investigate the Safety and Tolerability of SF2000SD in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Proportion of study participants with changes in blood hematological values after administration of test product. This will involve Full Blood Count (FBC) including differential for white blood cells
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of SF2000SD in adult male healthy volunteers
详细描述
INTRODUCTION: Treatment and management of people suffering from HIV, AIDS and opportunistic infections using conventional therapeutic interventions is beyond the reach of most governments because of the cost of imported medicines. The WHO has approved the strategy and promotion of the use of Traditional Medicine in Health Systems.
The primary health care places traditional medicines high on its list of priorities and emphasizes their easy availability and use. There is however a need for scientific validation of most potential medicinal plants available in many poor countries and research must focus on the safety and efficacy of these traditional medicines to support their widespread usage. This study intends to conduct a phase I clinical trial using the SF2000SD.
History of SF2000 use: The Sondashi Formula 2000, code named "SF2000" is a mixture of 4 plants. Patients suffering from HIV/AIDS have been using this traditional medicine for the management of their illness.
JUSTIFICATION:
A more acceptable dosage form i.e. a spray dried extract (SF2000SD) has been developed based on the SF2000 inventor's traditional preparation the commencement of a phase I clinical safety study involving eligible adult male health individual volunteers is warranted. Information will be collected to scientifically ascertain the safety of SF2000 in these volunteers paving the way for a phase II clinical study to be conducted after phase I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •To be eligible to participate in study, the participant should be;
- •Male aged 18 to 45 years.
- •Available in Ndola during the 10 weeks study duration.
- •Able to provide proof of residence.
- •Able to complete Consent Form
- •In good health as determined by the combination of medical history, physical examination, and clinical judgment and laboratory results following TDRC normal ranges. Urine dipstick for protein and blood should be negative or trace. If either is ≥1+, complete urinalysis will be obtained (UA). If microscopic UA confirms hematuria or proteinuria ≥ 1+, the volunteer is ineligible.
- •Serologically negative for HIV, HBV and HCV infection.
排除标准
- •Anyone who meets ANY of the following exclusion criteria will NOT qualify for enrolment into the study.
- •A history related to TB
- •Any of the following chronic illnesses: diabetes, asthma, hypertension, skin conditions.
- •On herbal medicine and/ or traditional medicines or immune boosting treatments
- •Received an investigational drug or herbal medicine not less than 2 months by the time of administration of the study dose
- •excessive alcohol consumption/alcohol abuse
- •HIV and/or HBV and/or HCV positive
研究组 & 干预措施
SF2000SD
The test product is a Sondashi Formula Spray dried extract (SF2000SD). It is derived from spray drying with water the Sondashi Formula (SF2000), which is a mixture of mixture of 4 plants. SF2000SD is packaged into capsules of 500mg and six capsules are taken twice, daily for 42 days. This drug has anti-HIV properties but in this study we are just looking at safety issues.
干预措施: SF2000SD (Biological)
Placebo
The placebo arm is composed of capsule containing 500mg of inactive ingredient (Microcrystalline Cellulose PH102 -240mg; Starch - 10mg; Magnesium Stearate -10mg; and Maltodextrin Unidry 20 - 240mg).
干预措施: Placebo (Biological)
结局指标
主要结局
Proportion of study participants with changes in blood hematological values after administration of test product. This will involve Full Blood Count (FBC) including differential for white blood cells
时间窗: 56 days
Proportion of study participants with clinical adverse events such as diarrhea, vomiting, changes in vital signs etc. associated with the test product
时间窗: 56 days
Proportion of study participants with changes in laboratory liver and renal values after administration of test product. These will include ALT, AST, ALP, Total biluribin, Glucose, Urea and Creatinine
时间窗: 56 days
次要结局
未报告次要终点